Seminars in oncology
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Seminars in oncology · Apr 1996
Review Comparative StudyUpdate: vinorelbine (navelbine) in non-small cell lung cancer.
Vinorelbine (navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Medicament, Paris, France), a novel semisynthetic vinca alkaloid, is the first drug approved by the Food and Drug Administration in over 20 years for the first-line treatment of ambulatory patients with unresectable advanced non-small cell lung cancer (NSCLS). In a multicenter, randomized US trial, single-agent vinorelbine produced response rates of 12%, compared with prior single-center studies demonstrating a response rate of 30%. Furthermore, in the US trial, median survival for patients receiving vinorelbine was 30 weeks, with a 1-year survival rate of 25%, compared with 22 weeks for 5-fluorouracil and leucovorin, with a 1-year survival rate of 16%. ⋯ The major dose-limiting toxic effect of vinorelbine is granulocytopenia. Vinorelbine has demonstrated a survival advantage in patients with advanced NSCLC in two controlled clinical trials and has been associated with a favorable safety profile associated with a low incidence of hospitalization. These findings would suggest that vinorelbine alone or in combination with cisplatin may be a cost-effective treatment for appropriate patients with advanced NSCLC.
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Seminars in oncology · Apr 1996
Clinical TrialPreliminary report on a phase I study of ifosfamide and vinorelbine (navelbine) in advanced non-small cell lung cancer.
Vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Medicament, Paris, France), a semisynthetic vinca alkaloid, and ifosfamide have each shown activity as a single agent and in various combination-chemotherapy regimens against non-small cell lung cancer. Vinorelbine usually has been given on a once-weekly schedule. We designed a phase I study adding escalating doses of vinorelbine on a novel schedule of 3 consecutive days to ifosfamide in a dose-intensive regimen with granulocyte colony-stimulating factor. ⋯ The maximum tolerated dose of vinorelbine given on days 1, 2, and 3 is 30 mg/m2 when given with ifosfamide at 1.6 g/m2 on days 1, 2, and 3 and granulocyte colony-stimulating factor support. Myelosuppression is the dose-limiting toxic effect. Future analyses of the data will report the overall response and survival rates in these patients.
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Seminars in oncology · Apr 1996
Clinical Trial Controlled Clinical TrialCisplatin and ifosfamide with various doses of vinorelbine (navelbine) in advanced non-small lung cancer.
From November 1992 to March 1994 we concluded a phase II trial of the combination of cisplatin 75 mg/m2 and ifosfamide 3 g/m2 on day 1 and increasing doses of vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Medicament, Paris, France). Group A was given vinorelbine 25 mg/m2 on day 1, group B 25 mg/m2 on days 1 and 8, and group C 25 mg/m2 on days 1 and 15 and 12.5 mg/m2 on day 8. Inclusion criteria were histologically proven non-small cell lung cancer, stage IIIB or IV disease, no underlying disease, performance status < 2, no previous chemotherapy or radiotherapy, not older than 75 years, and informed consent. ⋯ Dose intensity for vinorelbine was 8.1 mg/m2/wk in group A, 14.7 mg/m2/wk in group B, and 16.9 mg/m2/wk in group C. This study shows that increased dose intensity with vinorelbine is feasible and seems to increase the response rate and median survival, which was 28 weeks in group A and 38 weeks in group B. Median survival had not been reached in group C.
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Seminars in oncology · Feb 1996
Review Comparative StudyThe role of taxanes in the treatment of breast cancer.
The taxanes paclitaxel and docetaxel are undergoing extensive evaluation in women with breast cancer in the United States and in Europe. Their dose-limiting toxicity is neutropenia. Paclitaxel also causes peripheral neuropathy, while docetaxel can cause unpredictable and severe skin toxicity, as well as edema and effusions due to a capillary leak syndrome. ⋯ These results clearly indicate that the taxanes will become a standard component of initial chemotherapy for women with breast cancer. The definition of their actual role still requires an answer to the unresolved questions of their optimal dose and combination with other anticancer agents. Most importantly, the drugs should be prospectively evaluated in a randomized study using comparable doses and schedules to assess which of the two has the better therapeutic index in breast cancer.